Informationen:
Fehler:
ID
11320
Beschreibung
Study documentation part: Screening This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3.
Stichworte
Versionen (1)
- 6/30/15 6/30/15 -
Hochgeladen am
June 30, 2015
DOI
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Lizenz
Creative Commons BY-NC 3.0 Legacy
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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – Screening
Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – Screening
Ähnliche Modelle
Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – Screening
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Subject number
Item
Subject number:
integer
C1709561 (UMLS CUI-1)
Subject initial
Item
Subject initial:
text
C2986440 (UMLS CUI-1)
Visit date
Item
Visit date:
date
C0011008 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
C0545082 (UMLS CUI-2)
Date of birth
Item
Date of birth:
date
C0421451 (UMLS CUI-1)
CL Item
Male (1)
CL Item
Female (2)
CL Item
White (1)
CL Item
Black or African American (2)
CL Item
Asian (3)
CL Item
American Indian or Alaska Native (4)
CL Item
Native Hawaiian or Other Pacific Islander (5)
CL Item
Other Race (6)
Race
Item
If you chose the option "Other race" above, please specify:
text
C0034510 (UMLS CUI-1)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Informed consent
Item
Was informed consent obtained prior to any study related procedures?
boolean
C0021430 (UMLS CUI-1)
Date
Item
If you chose "Yes" above, please enter the date subject or legally authorized representative signed informed consent.
date
C0011008 (UMLS CUI-1)
Item Group
Eligibility criteria
C0332307 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
C1513905 (UMLS CUI-3)
C1516637 (UMLS CUI-4)
C0030705 (UMLS CUI-2)
C1513905 (UMLS CUI-3)
C1516637 (UMLS CUI-4)
Eligibility criteria
Item
Did the subject fail any eligibility criteria?
boolean
C0332307 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
C1513905 (UMLS CUI-3)
C1516637 (UMLS CUI-4)
C0030705 (UMLS CUI-2)
C1513905 (UMLS CUI-3)
C1516637 (UMLS CUI-4)
Failed criteria
Item
If you chose "Yes" above, record the failed criteria number(s) as specified in the protocol or on the Eligibility criteria worksheet as follow: Inclusion Number(s), Exclusion Number(s).
text
C0231175 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
C1512693 (UMLS CUI-3)
C0680251 (UMLS CUI-4)
C1516637 (UMLS CUI-2)
C1512693 (UMLS CUI-3)
C0680251 (UMLS CUI-4)
Item Group
Pre-randomization status
C0034656 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
Randomization
Item
Will the subject be randomized?
boolean
C0034656 (UMLS CUI-1)
Item
If you chose "No" above, please indicate primary reason for not being randomized?
text
C0034656 (UMLS CUI-1)
Code List
If you chose "No" above, please indicate primary reason for not being randomized?
CL Item
Adverse event (1)
CL Item
Subject withdrew consent (2)
CL Item
Death (3)
CL Item
Lost to follow-up (4)
CL Item
Poor/ Non-compliance (5)
CL Item
Pregnancy (6)
CL Item
Subject no longer meets study criteria (7)
CL Item
Administrative reason by sponsor (8)
CL Item
Other (9)
Reason
Item
Please specify if you chose "Subject withdrew consent" , "Poor/ Non-Compliance" , "Subject no longer meets study criteria" or "Other":
text
C0392360 (UMLS CUI-1)
Date
Item
Please specify the date of last contact, if you chose "Lost to follow-up":
date
C0011008 (UMLS CUI-1)
Item
Please choose the treatment group the subject is assigned:
text
C1522541 (UMLS CUI-1)
CL Item
70 mg twice daily (1)
CL Item
140 mg once daily (2)
Investigator's name
Item
Name of the investigator:
text
C2346576 (UMLS CUI-1)
C0027365 (UMLS CUI-2)
C0027365 (UMLS CUI-2)